Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx's First Quarter 2020 Results Conference Call. All participants are at present in a listen-only mode. Following the management's formal presentation, instructions will be given for the question-and-answer session. [Operator Instructions] I would now like to turn the call to Timothy McCarthy of LifeSci Advisors to read the Safe Harbor statement. Tim, please go ahead.

Thank you, operator. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. All statements in this conference call other than historical facts are indeed forward-looking statements. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project and other similar expressions are used typically to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other factors that may affect BioLineRx's business, financial condition and other operating results. These include, but are not limited to the risk factors and other qualifications contained in BioLineRx's Annual Report on Form 20-F, quarterly reports filed in the 6-K and other reports filed by BioLineRx with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. BioLineRx expressly disclaims any intent or obligation to update these forward-looking statements. At this time, it's now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Thank you, Tim, and good morning, everyone. And thank you for joining us on our first quarter earnings conference call today. Earlier this morning, we issued our Q1 results press release, a copy of which is available in the Investor Relations section of our website. It was also filed as a 6-K. I will begin with some brief prepared remarks and then, Mali Zeevi, our Chief Financial Officer will provide a short discussion of our financial results. We will then open up the call to your questions. Also joining the call for Q&A, are Abi Vainstein, our Vice President, Clinical Development; and Ella Sorani, our Vice President, Research and Development. Before turning to the results, I would like to make a comment about the humanitarian and economic crisis brought on by COVID-19. We, like many companies have quickly adapted to a remote working environment that puts our employees in the best position to remain safe while continuing to work toward our collective goals as a company. The pandemic has caused unprecedented disruptions in day-to-day activities and has resulted in delays to drug development timelines around the world given the difficulty of advancing ongoing trials and recruiting patients for new trials. Recall that our lead clinical candidate, motixafortide formerly BL-8040 is currently being evaluated in several studies across multiple cancer indications including advanced metastatic pancreatic cancer, stem cell mobilization in AML. We also have a second clinical candidate the anti-cancer vaccine AGI-134 that is being evaluated in solid tumors. We believe that having multiple clinical trials at various stages of completion will help us navigate through this crisis even while some of our programs may experience COVID-related delays. As currently contemplated, notwithstanding the pandemic, we believe we remain on track for three meaningful data readouts by the end of this year.…

Thank you, Phil. In our financial discussion, we will only go over a few significant items on this call. Research and development expenses and cash, Therefore, let me invite you to review the filings we made this morning, which contain our financials, operating and financial review and press release for additional information. Research and development expenses for the year ended March 31, 2020 were $5.4 million, an increase of $1 million or 23.5%, compared to $4.4 million for the comparable period in 2019. The increase resulted primarily from higher expenses associated with the COMBAT clinical trial, as well as an increase in share-based compensation. Turning to cash, the company held $21.2 million of cash, cash equivalents and short-term bank deposits as of March 31, 2020. We reiterate our previous cash guidance that our current resources are sufficient to fund our operations through our most significant clinical milestones. And with that, I will turn the call back over to Phil.

Thank you, Mali. In closing, I would like to take a few moments to summarize our upcoming data milestones this year. Progression-free survival and overall survival data from the COMBAT/KEYNOTE -202 Phase IIa triple combination study in mid this year; interim results from the Phase 2b AML consolidation study during the second half of this year; results from the Phase 3 GENESIS registrational in study stem cell mobilization also in the second half of this year; and finally, initial results from Part 2 of the Phase 1/2a trial of AGI-134, in the second half of 2021. We believe we have set the stage for a catalyst rich year, in spite of the pandemic and we look forward to providing future updates on our continued progress. With that, we have now concluded the formal part of our presentation. Operator, we will now open up the call to questions.

Thank you. [Operator Instructions] The first question is from Joe Pantginis of H.C. Wainwright. Please go ahead.

Hi everyone. Thanks for taking the question and hope you are all well. Phil, it’s great to see your leading milestones are remaining on track. So I just have a couple of logistical questions. First, with regard to the pancreatic study and I guess, even for all the studies, are you seeing any even modest dropouts due to COVID?

No, we haven’t seen any dropouts at all. First of all, it’s good to speak to you, Joe, first of all, and I also hope that you are well. But thankfully, we haven’t seen any issues in the BL-8040 studies. As mentioned, we have seen some issues in AGI-134. We thought it was the right thing to do to freeze the recruitment on that study and wait until things settle down, especially since that study is being managed mostly or the recruitment is mostly in the UK, which as you know is still suffering more than most places. But, like I said, the 8040 studies are – we are really not seeing any significant issue with the studies stemming from the COVID-19.

Got it. And then my second question actually has to do with 134 and again logistical here, would you disclose sort of the level of accrual that you had thus far and did you have any internal discussions to decide whether you would want to put out maybe some additional immunological data or PK data for – or not PK data, just basically immunological or translational data from the study that you have since it is open-label or you want to obviously maybe wait to have the most robust dataset possible?

Okay. Thanks for this one, Joe. Actually, we’ve been so conservative to publish data for very few patients who want to have more robust data to be able to present in the very thoughtful manner the data that we have, then and this stage we are not aiming to do that. And we are waiting for this COVID to go away and we would be able to begin again the recruitment in the UK and Israel as well as in the U.S.

Completely understandable and a sound clinical approach. Thanks a lot guys and be well.

Okay. You too. Thanks, Joe.

The next question is from Mark Breidenbach of Oppenheimer. Please go ahead.

Hey guys. Congrats on the progress, especially given the difficult circumstances and thanks for taking my questions. So, just following up on one of the previous ones, it sounds like there is not really a chance COVID-19 would cause the GENESIS trial to fall short of its enrollment target, if I am understanding correctly? And I am just wondering if you can comment if there any specific actions being taken to address COVID-related protocol deviations or missing follow-up data from GENESIS patients?

Thanks for the questions. Actually, also for the stem cell mobilization, we didn’t see any changes. At the beginning we have freed some sites recruitment but we are still on track with the recruitment as planned. Therefore, we don’t see that if COVID affect us in general. About the deviation, it’s a good question there. They put guidelines in regard to the deviation. They allowed more deviation but actually we didn’t see such a difference between before and after the COVID. Actually, the patients that need to be transplant, they come to the site and they are doing mobilization and further transplant. We are not receiving or having more deviation compared to before. But it is good to know that the FDA is more flexible due to the Coronavirus issue.

Okay. Got it. And assuming positive data from GENESIS, can you just go over any plans for a pre-NDA meeting later this year after the data are out? And I am also curious if you have an adequate stockpile of motixafortide to potentially support a 2021 launch?

Well, first of all, as you know, we haven’t made secret of the fact that we are looking for a collaboration partner for motixafortide for BL-8040. And so, our plans have not changed in that regard that to go – to find a partner and I would conceive - it’s conceivable that any partner would want to participate in any type of pre-NDA meeting with the FDA. Having said that, we are getting the data together and doing whatever is necessary including validation, batches, et cetera, et cetera of BL-8040 in order to move forward and be prepared for a pre-NDA meeting, an NDA submission, et cetera, et cetera. But like I said, I think, it would make sense that since we are in parallel speaking with potential collaboration partners it would make sense to do that together with them.

Okay. Understood. And one last quick one from me. Can we assume the COMBAT/KEYNOTE-202 results will be presented at a major medical meeting? And is there a guidance for mid-year data kind of inclusive of late – through the third quarter ASMO timeframe? Just curious on that. Thanks.

Yes. So, we are very excited about the opportunity to present at one of the conferences mid-year. And so, I can’t give you any more information in mid-year. But you should look for it in the early summer I guess, would make sense.

Okay. That’s helpful. Thank you so much.

[Operator Instructions] There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin two hours after the conference. In the U.S. please call 1-888-782-4291. In Israel, please call 03-925-5928. Internationally, please call 972-3925-5928. Mr. Serlin, would you like to make your concluding statement?

Yes, I would. Thank you. That concludes our call this morning. I'd like to thank you again for your interest in BioLineRx and we look forward to providing future updates on our continued progress. Be safe and have a great day.

Thank you. This concludes the BioLineRx first quarter 2020 conference call. Thank you for your participation. You may go ahead and disconnect.